# US 5,707,810 A · Method of diagnosing renal tissue damage or disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,707,810 A - Document ID: US5707810A - Status: Granted - Kind: A - Application number: 08/643,563 - Filed: 1996-05-06 - Granted: 1998-01-13 - Earliest claimed: 1991-03-11 - Assignees: Creative BioMolecules, Inc. - Inventors: John E. Smart; Hermann Oppermann; Engin Ozkaynak; Thangavel Kuberasampath; David C. Rueger; Roy H. L. Pang; Charles M. Cohen - Web page: https://patentgrep.com/patent/US5707810A ## CPC - G01N 33/74: involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors} - A61K 38/17: from animals; from humans {(enzyme inhibitors A61K38/005)} - A61K 38/1703: {from vertebrates} - A61K 38/1875: {Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor} - A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24} - A61L 27/24: Collagen - C07K 14/51: Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor - C07K 14/625: Extraction from natural sources - C07K 16/22: against growth factors {; against growth regulators} - C12Q 1/6881: for tissue or cell typing, e.g. human leukocyte antigen [HLA] probes - G01N 33/6893: {related to diseases not provided for elsewhere} - A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof - C12Q 2600/158: Expression markers - G01N 2500/10: involving cells - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract In one aspect, the present invention provides a method of diagnosing renal tissue damage or disease by measuring endogenous expression of OP-1 by renal tissue of a mammal (e.g., a human) in which a depression of endogenous expression relative to undamaged or undiseased mammalian renal tissue indicates a diagnosis that the mammal is afflicted with renal tissue damage or disease. Also disclosed are methods of diagnosing renal tissue damage or disease in a mammal. The methods involve detecting and/or measuring the expression of the OP-1 (BMP-7) gene or protein in the mammal. Depression of OP-1 expression may be used to diagnose renal tissue damage or disease. ## Claims ### Claim 1 A method of diagnosing renal tissue damage or disease comprising the step of measuring endogenous expression of OP-1 by renal tissue of a mammal, wherein a depression of said endogenous expression relative to undamaged or undiseased mammalian renal tissue indicates a diagnosis that said mammal is afflicted with said damage or disease. ### Claim 2 (depends on 1) The method of claim 1 wherein said endogenous expression is measured by detecting OP-1 mRNA in renal tissue of said mammal. ### Claim 3 (depends on 1) The method of claim 1 wherein said endogenous expression is measured by detecting OP-1 protein produced by renal tissue of said mammal. ### Claim 4 (depends on 3) The method of claim 3 wherein said endogenous expression is measured by detecting OP-1 protein circulating in said mammal. ### Claim 5 (depends on 4) The method of claim 4 wherein said endogenous expression is measured using an antibody specific for said OP-1 protein. ### Claim 6 (depends on 1) The method of claim 1 wherein a depression of said endogenous expression relative to undamaged or undiseased mammalian renal tissue indicates that said mammal is afflicted with renal tissue degeneration. ### Claim 7 (depends on 6) The method of claim 6 wherein a depression of said endogenous expression relative to undamaged or undiseased mammalian renal tissue indicates that said mammal is afflicted with kidney disease. ### Claim 8 (depends on 1) The method of claim 1 wherein said mammal is human. ### Claim 9 A method of diagnosing renal tissue damage or disease comprising the steps of: (a) contacting a sample of mammalian renal tissue with an agent for specifically detecting endogenous expression of OP-1 in said tissue; (b) detecting whether OP-1 is expressed endogenously in said tissue; and (c) diagnosing said damage or disease if said expression is absent. ### Claim 10 A method of diagnosing renal tissue damage or disease comprising the steps of: (a) contacting a sample of mammalian renal tissue with an agent for specifically detecting endogenous expression of OP-1 in said tissue; (b) detecting a level of endogenous expression of OP-1 in said tissue; and (c) comparing said level of endogenously expressed OP-1 in said tissue with a reference level of OP-1 endogenously expressed in undamaged or undiseased mammalian renal tissue to diagnose said damage or disease. ### Claim 11 (depends on 9, 10) The method of claim 9 or 10 wherein said agent is a nucleic acid probe that hybridizes specifically with RNA transcribed from an OP-1 gene present in cells of said tissue. ### Claim 12 (depends on 11) The method of claim 11 wherein said probe hybridizes specifically with RNA encoding an OP-1 polypeptide. ### Claim 13 (depends on 12) The method of claim 12 wherein said probe hybridizes specifically with RNA encoding a nonconserved fragment of said OP-1 polypeptide. ### Claim 14 (depends on 13) The method of claim 13 wherein said fragment is located N-terminal to a conserved C-terminal seven-cysteine domain of a mature OP-1 polypeptide. ### Claim 15 (depends on 13) The method of claim 13 wherein said fragment is located in the prodomain of said OP-1 polypeptide. ### Claim 16 (depends on 11) The method of claim 11 wherein said probe hybridizes specifically with RNA transcribed from a 3' noncoding region immediately following the stop codon of said OP-1 gene. ### Claim 17 (depends on 11) The method of claim 11 comprising the additional step of extracting poly(A)+RNA from said sample, said agent being contacted in step (a) with said poly(A)+RNA. ### Claim 18 (depends on 17) The method of claim 17 comprising the further additional step of blotting said poly(A)+RNA onto a nitroceilulose membrane. ### Claim 19 (depends on 18) The method of claim 18 comprising the still further additional step of electrophoretically fractionating said poly(A)+RNA prior to said step of blotting. ### Claim 20 (depends on 19) The method of claim 19 wherein said nucleic acid probe hybridizes specifically with a 4.0, 2.4, 2.2 or 1.8 kb RNA transcript of said OP-1 gene. ### Claim 21 (depends on 11) The method of claim 11 comprising the additional steps of: (a) contacting a sample of said mammalian renal tissue with a control nucleic acid probe that hybridizes specifically with RNA transcribed from a gene expressed uniformly in mammalian tissues; (b) detecting a level of expression of said gene in said tissue; and (c) comparing the endogenous expression level of OP-1 with the expression level of said gene. ### Claim 22 (depends on 21) The method of claim 21 comprising the further additional step of comparing the relative expression levels of OP-1 and said gene in said tissue, with the relative expression levels of OP-1 and said gene in undamaged or undiseased mammalian renal tissue. ### Claim 23 (depends on 21) The method of claim 21 wherein said gene is transcriptional elongation factor. ### Claim 24 (depends on 9, 10) The method of claim 9 or 10 wherein said mammalian renal tissue is human renal tissue. ### Claim 25 (depends on 24) The method of claim 24 wherein said tissue is obtained from a human afflicted with renal tissue damage. ### Claim 26 (depends on 25) The method of claim 25 wherein said human is afflicted with renal tissue degeneration. ### Claim 27 (depends on 26) The method of claim 26 wherein said human is afflicted with kidney disease.